For medical device manufacturers located outside the United States, appointing an FDA US Agent is a mandatory requirement for legally marketing devices in the U.S. market. Count on Sobel to act as your US Agent and gain reliable representation, clear communication, and full support in navigating U.S. regulatory expectations.
Let Sobel help you enter and thrive in the U.S. medical device market with clarity and confidence.
Appointing an FDA US Agent is mandatory for non-U.S. manufacturers seeking U.S. market access and maintaining establishment registration.
Efficient communication with FDA authorities helps prevent delays, miscommunication, and compliance gaps during submissions, inspections, and post-market events.
A qualified US Agent ensures you meet regulatory obligations while gaining strategic support to navigate U.S. requirements.
Sobel acts as your official point of contact in the United States, handling regulatory communication, coordinating inspections, and supporting your establishment registration and product listings.
Depending on your company’s objectives and supplier risk level, you can request a medical device supplier audit, a supplier qualification, or a complete audit + qualification package.
Best for companies needing a structured, independent evaluation based on applicable standards. The audit reviews document and record control, service provision, product and process verification, and the supplier’s own qualification process. Conducted remotely.
Ideal when you need to formally qualify suppliers according to your company’s quality standards. This service evaluates documentation and compliance criteria provided by the supplier and results in a supplier qualification report.
Recommended for manufacturers seeking comprehensive supplier assurance. This combined approach includes a full supplier audit plus a formal qualification review, offering complete visibility into documentation, processes, conformity, and supplier reliability—ideal for critical suppliers or high-risk categories.
Our supplier auditing and qualification approach is built around clarity, objectivity, and traceability. Trust a team with proven experience in supplier compliance and regulatory expectations.
Sobel provides fast, accurate, and compliant communication to support your U.S. market access. Beyond our FDA US Agent service, your company can also count on additional support with:
Expert-led training programs that strengthen risk management and compliance.
Support for CEP and CER development, including strategic planning, literature reviews and more.
Strengthen your supply chain with supplier audit and qualification services.
Entering the U.S. market requires precise communication, accurate documentation, and a trusted liaison with FDA authorities. With Sobel as your FDA US Agent, your company gains structured support, rapid responsiveness, and regulatory clarity—so you can focus on innovation, safety, and long-term growth.
1. What is an FDA US Agent and why is it required?
An FDA US Agent is a representative located in the United States who acts as the official liaison between a foreign medical device manufacturer and the FDA. The role is mandatory for companies without a physical presence in the U.S. and is required for establishment registration under 21 CFR 807.40.
2. Does every foreign medical device manufacturer need an FDA US Agent?
Yes. Any company outside the United States that manufactures, imports, or intends to market a medical device in the U.S. must appoint a registered FDA US Agent.
3. What responsibilities does an FDA US Agent have?
The U.S. Agent assists the FDA in communication with the foreign establishment, responds to questions about imported devices, coordinates FDA inspections, and receives regulatory documents if the FDA cannot reach the manufacturer directly. The agent also supports establishment registration and product listing updates.
4. How does an FDA US Agent assist during inspections?
The US Agent helps the FDA schedule and coordinate inspections of the foreign establishment. They do not host or participate in the inspection itself, but they act as the communication channel to ensure the process moves smoothly.
5. What happens if the manufacturer changes address, ownership, or contact details?
The manufacturer must notify the FDA US Agent immediately. Failure to update these details can result in registration issues or delays in FDA communication.
6. Can a distributor or importer serve as the FDA US Agent?
Yes, but appointing a distributor or importer as your FDA US Agent is generally discouraged. They may have commercial interests that conflict with regulatory responsibilities, potentially delaying or filtering critical FDA communication. Most manufacturers prefer a neutral, independent representative—such as Sobel—to ensure timely, transparent, and fully compliant interaction with FDA authorities.
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